On December 23, 2019, the Food and Drug Administration (FDA) issued a proposed rule and draft guidance to implement and facilitate two pathways for the legal importation of certain drugs, which the FDA and the Department of Health and Human Services (HHS) first described in a July 31, 2019 Safe Importation Action Plan. A summary of the Safe Importation Action Plan can be found in Arnold & Porter's August 2, 2019 advisory. The proposed rule, entitled "Importation of Prescription Drugs" (Pathway 1 Proposed Rule), implements "Pathway 1" of the action plan by proposing to authorize states, tribal or territorial governmental entities, wholesalers, or pharmacists to submit proposals outlining plans to import certain types of prescription drugs from Canada via time-limited Section 804 Importation Programs (SIPs).
The draft guidance, entitled ''Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act'' (Pathway 2 Draft Guidance), addresses "Pathway 2" of the Safe Importation Action Plan. The Pathway 2 Draft Guidance describes procedures that drug manufacturers can follow to facilitate importation of their prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in a foreign country, and originally intended for sale in that foreign country.
Please see below for a Questions & Answers overview of the key aspects of the Pathway 1 Proposed Rule and Pathway 2 Draft Guidance. Comments on the Pathway 1 Proposed Rule are due by March 9, 2020, and comments on the Pathway 2 Draft Guidance are due by February 21, 2020.
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